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Eyevensys Appoints Dr Ronald R. Buggage as Chief Medical Officer

Eyevensys Appoints Dr Ronald R. Buggage as Chief Medical Officer 2500 1667 Eyevensys

Paris (France), 4th September 2017 – Eyevensys, a clinical stage biotech company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces today the expansion of its executive team with the addition of Dr Ronald R. Buggage as its Chief Medical Officer. Dr Buggage brings more than 14 years’ experience from both large pharma and biotech companies having worked in senior development positions in the US and Europe. Dr Buggage will drive the Company’s drug development strategy, overseeing clinical development programs for a broad range of ophthalmic indications based Eyevensys’ unique non-viral gene therapy EyeCET platform.

Dr Buggage was most recently Division Medical Officer at Sanofi’s Ophthalmology Unit, responsible for the leadership and coordination of medical and scientific activities for its ophthalmology portfolio including development programs for ocular gene therapy. He also served as Chief Scientific Officer of Novagali Pharma, where he was responsible for the global clinical and regulatory strategy; Novagali Pharma was successfully acquired by Santen. Prior to moving to France, Dr Buggage held various positions of increasing clinical development responsibility at Novartis and Pfizer. Dr Buggage obtained his MD at UCLA School of Medicine, specializing in ophthalmology at Emory, and completed his training in ocular immunology and uveitis at the National Eye Institute of the National Institutes of Health (NIH).

Raffy Kazandjian, CEO of Eyevensys, said, “We are delighted to add such an experienced and high-calibre individual to our executive team. Ronald’s unique combination of regulatory, medical, and drug development expertise in the ophthalmic space, including uveitis, will be a major asset as Eyevensys advances its high potential pipeline. This includes our lead product EYS606 for which the first in human phase I/II clinical trial was recently initiated in France.”

He added, “Eyevensys has a unique approach to treating ophthalmic diseases based around our proprietary EyeCET platform that we believe is the only non-viral technology that enables the safe local sustained production of therapeutic proteins in the eye for up to six months. I am confident that our approach will have a clear appeal to physicians and patients, offering them a clearly differentiated alternative to existing treatments for major ophthalmic indications.”

Dr Ronald R. Buggage, CMO of Eyevensys, commented, “I am particularly thrilled to join Eyevensys at such a pivotal time. Its proprietary EyeCET platform offers an innovative approach to sustained intraocular drug delivery which combined with the non-viral delivery of the plasmids provides a convenient alternative to current biologics used to treat ophthalmic diseases. I believe that with EyeCET, Eyevensys has the potential to build an exciting, high value pipeline of new ocular therapies.”

Eyevensys Announces the First-in-Human Treatment with its GroundBreaking EyeCET ElectroTransfection Technology for Eye Diseases

Eyevensys Announces the First-in-Human Treatment with its GroundBreaking EyeCET ElectroTransfection Technology for Eye Diseases 2500 1667 Eyevensys

Eyevensys announces today that it has successfully treated the first patient in a first-in-human phase I/II trial of its lead candidate EYS606 for Non-Infectious Uveitis (NIU). The patient was treated in Paris, France at the Cochin Institute by Professor Antoine Brézin, the principal investigator of the trial, using the company’s novel EyeCET technology.

EYS606 is the first non-viral gene therapy that has the potential to treat NIU patients as replacement of systemic therapy or repeated intra-vitreal injections. EYS606 is based on Eyevensys’ EyeCET technology, which uses a proprietary electro-transfection injection system (ETIS) to deliver a plasmid encoding for the production of an anti-TNFα therapeutic protein into the ciliary muscle of the eye. TNFα is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU patients.

The phase I/II trial aims to demonstrate the safety and tolerability of the EYS606 treatment when the plasmid component of EYS606 is administered using EyeCET technology by electro-transfer into the ciliary muscle of patients with non-infectious posterior, intermediate or pan uveitis. The treatment procedure, which takes less than 5 minutes, is designed to provide the patient with a local, safe and sustained treatment, obviating the need for monthly injections. This open-label, multicentre dose escalation study will enrol up to 24 patients in France and the UK and the initial trial results are expected in the first half of 2018.

EYS606 has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU.

Professor Francine Behar-Cohen, Founder and Chief Scientific Officer of Eyevensys, stated: “Successfully treating our first patient is an important step towards improving outcomes for patients with NIU. This is the first time plasmid DNA has been successfully delivered to the eye via electro-transfection. This represents a major milestone for Eyevensys and a key step in validating the potential of our EyeCET platform to provide safe and long-lasting treatments for patients while avoiding the current standard of multiple injections and their associated safety risks.”

Professor Brézin, Cochin Institute, and principal investigator of the study in France, stated: “I am delighted to be part of this landmark clinical study using Eyevensys’ unique EyeCET platform. This first treatment was very well tolerated by the patient, which represents an important step towards potentially improving outcomes for patients with NIU. NIU is a rare and severe eye condition afflicting approx. 25,000 in France and there is a critical need for novel treatments.”

Eyevensys Receives Approval from the UK Medicines and Healthcare products Regulatory Agency to advance its EyeCET platform into clinical development

Eyevensys Receives Approval from the UK Medicines and Healthcare products Regulatory Agency to advance its EyeCET platform into clinical development 2500 1668 Eyevensys

Eyevensys, a private biotechnology company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to advance its technology into clinical development.

The EyeCET platform uses Eyevensys’ proprietary electro-transfection injection system (ETIS) to deliver plasmids that encode for the production of disease-specific therapeutic proteins in the ciliary muscle of the eye. Eyevensys’ lead product, EYS606 uses a plasmid encoding for the production of anti-TNFα for the treatment of Non-infectious Uveitis (NIU). EYS606 has been granted an Orphan drug designation by the EMA for the treatment of NIU.

Raffy Kazandjian, CEO of Eyevensys, said: “We are pleased the MHRA has approved our unique technology to enter into clinical development in the UK. This validation is another commitment of EYS606 alongside the ANSM approval. We are now all set up to demonstrate that our technology can provide much better outcomes for patients with ophthalmology diseases that need improved treatment options.”

Eyevensys Receives Approval from the French Product Security Regulatory Agency ANSM to advance its EyeCET platform into clinical development

Eyevensys Receives Approval from the French Product Security Regulatory Agency ANSM to advance its EyeCET platform into clinical development 2500 1667 Eyevensys

Eyevensys, a private biotechnology company developing its proprietary EyeCET platform, the first non-viral gene expression technology that enables the safe, local, sustained production of therapeutic proteins in the eye to address a wide range of ophthalmic diseases, announces it has received approval from the French product security regulatory agency “Agence Nationale de Sécurité du Médicament” (ANSM) to advance its technology into clinical development.

The EyeCET platform uses Eyevensys’ proprietary electro-transfection injection system (ETIS) to deliver plasmids that encode for the production of disease-specific therapeutic proteins in the ciliary muscle of the eye. Eyevensys’ lead product, EYS606 uses a plasmid encoding for the production of anti-TNFα for the treatment of Non-infectious Uveitis (NIU). EYS606 has been granted an Orphan drug designation by the EMA for the treatment of NIU.

Raffy Kazandjian, CEO of Eyevensys, said: “This clearance from the ANSM is a landmark achievement for Eyevensys given the unique features of EYS606, which combines an anti-TNFα plasmid with a novel and unique medical device, designed to carry out an electroporation procedure. We are now in a position to   demonstrate that our EyeCET technology can provide ophthalmology patients with much needed and improved treatment options. We plan to start our first Phase I trial with EYS606 shortly.“

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